The Reactiv8 device for back pain, a qualitative study
Research type
Research Study
Full title
A prospective qualitative study of patients undergoing treatment with Reactiv8: pre and post-implantation.
IRAS ID
288586
Contact name
Nicholas Harland
Contact email
Sponsor organisation
Sunderland University
Duration of Study in the UK
2 years, 0 months, 3 days
Research summary
There are very few treatment options for chronic back pain patients who have undergone unsuccessful usual care involving interventions such as CBT, exercise and Physiotherapy. Reactiv8 is a surgically implanted device that stimulates the nerves supplying some of the back muscles thought to become weak and inhibited because of back pain. This device is new but due to positive research outcomes now has FDA approval/CE Mark and is being used/implanted in three NHS centres and other centres internationally.
The purpose of this prospective study is to interview ten patients shortly before they undergo Reactiv8 implantation, and six months after implantation, using semi-structured interviews. Interviews will explore the qualitative experiences of those patients including what life was like before implantation and since starting to use the device.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
20/EM/0281
Date of REC Opinion
16 Nov 2020
REC opinion
Favourable Opinion